Vocsn High Flow Kit
The Ventec High Flow Nasal Cannula Kit contains the following items: - 5x Adult, Valveless Heated Ventec One-Circuit (00855573007235) - 5x Humidifier Bypass (00855573007136) - 5x Optiflow+…
The Ventec High Flow Nasal Cannula Kit contains the following items: – 5x Adult, Valveless Heated Ventec One-Circuit (00855573007235) – 5x Humidifier Bypass (00855573007136) – 5x Optiflow+ Adult Cannula, Medium (09420012429117) – 5x Auto-fill Disposable Adult Humidification Chamber (09420012432025) – 1x High Pressure O2 Hose (14896138006587) – 1x Temperature Probe (09420012401311) – 1x 850 Heater Wire Adapter (09420012421548) – 1x Water Bag Pole (09420012405920) – 1x MR850 Heated Humidifier (09420012407290)
Who Else Makes It
Concentrated in Guangdong (4), Jiangsu (2), Fujian (1). 6 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| GaleMed (Xiamen) Co., Ltd. | Xiamen | Fujian | Contract manufacturer | 33 |
| Vincent Medical (Dong Guan) Manufacturing Co., Ltd. | Dong Guan | Guangdong | Contract manufacturer | 29 |
| Sanmina | Kunshan | Jiangsu | Contract manufacturer | 15 |
| Mehow Innovative (Huizhou) Ltd. | Huizhou | Guangdong | Contract manufacturer | 11 |
| Respironics Medical Products (Shenzhen) Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 8 |
| Beijing Aeonmed Co., Ltd. | Sanhe | Hebei | Contract manufacturer | 7 |
| Shenzhen Mindray BIO-Medical Electronics Co., Ltd. | Shenzhen | Guangdong | Specification developer | 61 |
| GE Medical Systems (China) Co., Ltd. | Wuxi | Jiangsu | Contract manufacturer | 57 |
Record
| Listed by | Ventec Life Systems, Inc., United States |
|---|---|
| FDA product code | CBK |
| Device type | Ventilator, Continuous, Facility Use |
| Device class | Class 2 |
| Regulation | 21 CFR 868.5895 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Record published | 2020-10-05 |
| Record revised | 2025-12-10 (version 2) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Single use | Yes |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, manufacturing date, serial number |
| Storage | Storage environment temperature -13 to 122 °F |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 5-Week High Flow Nasal Cannula Kit | In distribution | |
| 5-Week High Flow Nasal Cannula Kit | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Puritan Bennett | Covidien LP | 285 |
| Newport | Newport Medical Instruments, Inc. | 103 |
| LTV | Vyaire Medical, Inc. | 92 |
| Ventilator, Continuous, Facility Use | Hans Rudolph, Inc. | 66 |
| Infant Flow SiPAP | Carefusion | 62 |
| Avea | Carefusion | 57 |
| Ventoux | Flight Medical Innovations Ltd. | 48 |
| Trilogy | Respironics Inc. | 42 |
| Avea™ | Vyaire Medical, Inc. | 39 |
| Patient Circuits | Zoll Medical Corporation | 38 |
| Performatrak | Respironics Inc. | 35 |
| Bio-Med Devices, Inc. | BIO-MED Devices, Inc. | 34 |
Showing 12 of 419. All products under Ventilator, Continuous, Facility Use
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K162877 | 2017-04-07 |
Recalls
2 of these are Class I. Class I is the FDA’s most serious grade: a reasonable probability of serious injury or death. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|
| 2026-05-08 | Class II | Vendor change control | Respiratory system intended to provide continuous/intermittent ventilator support, may have a damaged back-up battery supporting backup alarm function, which may result in the backup alarm not activating during loss of primary power and abs | 1 |
| 2025-02-03 | Class I | Component change control | Multi-Function Ventilators were serviced using incorrect parts which have the potential to cause unexpected shutdown, or when using an active circuit could result in inaccurate tidal volume monitor, not triggering on patient efforts, less i | 30 |
| 2024-01-09 | Class I | Process control | The bonded spiral wrap may detach before or during ventilation due to a manufacturing issue. Detachment of the spiral wrap can compromise structural integrity, functionality and/ or performance resulting in occlusions or leaks of the breat | 250 breathing circuits |
| 2021-05-10 | Class II | Device Design | Due to a component failure, ventilators may unexpectedly shut down or have a loss of blower function while in patient use. The shutdown potentially prevents the ventilator from providing ventilation therapy. | 1,934 devices (415 device that have not been updated) |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.